FDA Quietly Plots Pilot Program For Virtual Inspections As Pandemic Rages On
The COVID-19 pandemic is nudging the US FDA to launch a voluntary pilot program that will allow agency investigators to conduct facility inspections virtually, King & Spalding’s Steve Niedelman said on 11 November.
You may also be interested in...
The coming pilot program would give the US FDA remote access to a manufacturer’s records. It’s another approach the agency wants to try as it feels out the best way to virtually evaluate regulatory compliance during the COVID-19 pandemic.
The US FDA is assessing via a pilot program whether the use of video is helpful when investigators perform remote facility inspections. Meanwhile, the agency’s device center is “working on alternative approaches for assessing a firm’s quality management system,” an FDA official says.
‘What, Me Worry?’: Experts Say They’re Not Concerned About FDA Restarting Domestic Inspections Amidst COVID-19
In a few days the US FDA will fire up its domestic inspectorate for the first time since March. But is it a good idea? Three industry experts said during a Food and Drug Law Institute webinar that they’re not particularly worried.